Recruiting

Hymovis

Sponsor:

National Jewish Health

Code:

NCT04093232

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Hymovis

Study Details

Brief summary:

This NJH Investigator Initiated Study funded by Fidia will prospectively perform 2 ultrasound (US) guided knee aspirations in patients with knee osteoarthritis using a pneumatic compressive device (KneeTap ™) at baseline and at 3 months following 2 Hymovis® injections. Synovial fluid catabolic and anabolic proteins will be compared to those values in the peripheral blood and correlated with clinical outcome measurements at 3 ,6 and 12 months compared to baseline values; WOMAC, SF 36, visual analog pain scale, 6 minute walking distance and SF volumes quantitated by US.

Conditions

Knee Osteoarthritis

Study ID

NCT04093232

Start date

Jan 1, 2019

Status verified date

Mar, 2021

Completion date

Feb 1, 2022

Anticipated

Primary completion date

Jan 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Mild to moderate knee osteoarthritis on x ray
  • age 21-80

Exclusion Criteria

  • pregnant
  • BMI > 40
  • history of systemic immune disorders
  • knee arthroplasty with replacement
  • knee infection or surgery within 1 year
  • glucocorticoid injection within 3 months inability to ambulate for 6 minutes without walking assistive devices
  • unable to provide informed consent
  • patients with a clinical contra-indication for an arthrocentesis or adverse reaction to prior intra-articular lidocaine or HA injections.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Hymovis

All subjects will receive 2 ultrasound guided Hymovis injections and the goal of the study is to correlate responsiveness to subjects unique SF biomarker panel results before the first Hymovis injection and identify potential mechanism of action of those OA patients who receive the greatest benefit.

Primary outcome measure

  • WOMAC scores (Western Ontario and McMaster University Osteoarthritis Index) [ Time Frame: Change from baselinescore values to those over 12 months ]
  • SF 36 scores (Quality of Life Questionnaire) [ Time Frame: Change from baseline score values to those over 12 months ]
  • VAS (Visual analogue scale) score for self reported pain [ Time Frame: Change from baseline score values to those over 12 months ]
  • 6 minute walking distance [ Time Frame: Change in distance walked from baseline to that distance walked over 12 months ]
  • Synovial fluid depth [ Time Frame: Change in the depth of knee synovial fluid from baseline values to those at 12 months ]

Central Contacts and Locations

Central contacts

Mary Gill, MD

303 398 1443gillm@njHealth.org

richard T Meehan, MD

303 398-1475meehanr@njHealth.org

Locations

national Jewish health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Mary Gill, RN

303-398-1443Gillm@njhealth.org

richard T Meehan, MD

303 398-1474meehanr@njhealth.org

More Information

Sponsor

National Jewish Health

Last update posted

Mar 3, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2021-03-03.